Home-monitoring system for Lower Extremity Amputation Prevention (LEAP) for patients with diabetes at high risk of ulceration

Home-monitoring system for Lower Extremity Amputation Prevention (LEAP) for patients with diabetesat high risk of ulceration: Project SummaryFoot ulceration, often on the plantar surface, is the most common and costly late complication of diabetes (1-4), with morbidity and mortality being worse than many cancers. In 2014, diabetic foot ulcers (DFUs) cost Medicare an estimated $18.7 billion (5,6). Pathways to ulceration are well defined: peripheral neuropathy results in insensitivity, and repetitive stress on high pressure areas leads to inflammation and warming, thus the foot warms up before it breaks down, often without warning symptoms (1,3,7). Due to loss of sensation, patients have poor appreciation of their DFU risk, resulting in a lack of preventive foot self-care (8). Information-alone focused education that does not allow patients to visualize and monitor their DFU risk has not succeeded in reducing the incidence of ulceration (9) In contrast, education together with patient self-foot- temperature monitoring, can lead to a reduction in recurrent ulcer incidence (10,11). Lavery et al confirmed that self-foot temperature monitoring in those with past DFU is associated with a significant reduction in new DFU compared to standard of care (11). A recent study using remote self-foot temperature monitoring showed that an asymmetry of 2.2°C between the two feet of patients with a DFU history predicted 97% of DFU recurrence (12) and reported promising levels of adherence to self-monitoring.Arche Healthcare’s tools and technology are designed to increase patients’ recognition of their DFU risk by literally making it visible to them, and to increase monitoring adherence by using technology prompts rather than relying solely on patient self-motivation. Arche Healthcare’s current foot temperature home-monitoring device, TempStat®, allows for easy identification of areas of elevated temperature (13). Using patented liquid crystal thermography (LCT), the leading technology (14), TempStat takes about 60 seconds to produce a thermal image of the soles of the feet. An embedded mirror allows for visual inspection by the patient. Building on this user-friendly foot temperature monitoring device, Arche Healthcare plans to revolutionize home diabetic foot screening by integrating two components into the existing OPTYX® clinical information system: The Insight® hardware device (modified TempStat) and the VeriSole® mobile application (app). In the InSight device, the mirror will be replaced with a scanner that will transmit an image of the bottoms of the patient’s feet to their phone or tablet via VeriSole. The app will track adherence to daily foot temperature monitoring and incidences of skin temperature elevation, and will alert the patient and their provider, through their dashboard in Arche’s OPTYX proprietary clinical information system, as to imminent DFU risk. If the patient fails to monitor and/or take an appropriate action in response to a ‘hot spot,’ the physician will be informed. Funding is therefore requested to 1) complete development of InSIght/Verisole which will evolve TempStat into a 21st Century state of the art home monitoring device for those at risk of DFU, and to 2) test its usability with groups of patients at high risk of DFU and their health-care professionals.Project NarrativeLower extremity diabetic complications in the United States result in infections in 58% of patients presenting with a new foot ulcer (15), represent the commonest cause of hospitalization among people with diabetes with annual direct costs of over $50 billion (1), and five-year mortality rates as high as 45% for neuropathic ulcers and 55% for ischemic ulcers (15).Since 2009, Arche Healthcare has distributed, via physician prescription, over 8000 TempStat® units, a proprietary, FDA registered, Class 1 medical home temperature monitoring device that uses liquid crystal technology to produce a thermal image of the feet, allowing patients to identify pre-ulcerative areas of plantar inflammation called ‘hot spots’ (13).Arche Healthcare now presents plans to evolve TempStat to the next generation home monitoring system, comprised of InSight®, which augments TempStat with a scanner and a proprietary application (app) called VeriSole®, that connects to a mobile device and the Arche OPTYX® Platform, thus literally putting the patient’s feet into their own hands, to accomplish the following:• track incidents of skin temperature elevation,• track patient adherence to use of the device and alert the healthcare provider if it is not being used,• allow the patient to inspect the bottom of their feet via a scanned image presented on their mobiledevice via the app, and• alert both the patient and his or her health care provider to the risk of imminent ulceration,thus permitting timely preventative measures to be initiated ultimately driving a reduction inthe incidence of DFU and LEAs.